Food, drugs, devices › Baxter Corporation Englewood
Device recall: Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445
Baxter Corporation Englewood (Englewood, CO) initiated this device recall on 4 Dec 2014; FDA lists 1 product record under event 69934, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 30 Nov 2016. Initiation: voluntary: firm initiated. Baxter Corporation Englewood has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Baxter Corporation Englewood, Englewood, CO.
Reason for recall
"Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation."
Distribution
"Worldwide Distribution - US Distribution to the states of UT, TX, and IL, and to the countries Austria, Germany, Spain, Switzerland, and Netherlands. No VA/military/govt consignees."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0871-2015 | Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile | 54,000 | Class II | Terminated | 31 Dec 2014 |
Context
Other enforcement events for Baxter Corporation Englewood
All 9 events for Baxter Corporation Englewood
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Distribution to the states of UT, TX, and IL, and to the countries Austria, Germany, Spain, Switzerland, and Netherlands. No VA/military/govt consignees."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Nov 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.